Catheters and catheter mating devices and systems

ABSTRACT

Described is a catheter for being retained inside the body for extended periods, and a catheter mating device that can connect to the catheter to move the catheter inside of the body or remove it from the body. The catheter mating device has a stem with an apparatus at its distal end. The apparatus is moveable between a first position and a second position. When in its first position, the distal end is configured to fit in the proximal end of the catheter. When in its second position, the distal end engages the proximal end of the catheter and connects the catheter mating device to the catheter.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of, and claims priority to,U.S. application Ser. No. 15/072,345 to Herrera et al., entitledExtended-Use Valved Urinary Catheter filed on Mar. 16, 2016, which is acontinuation in part of and claims priority to PCT Application SerialNo. PCT/US2016/014648 entitled Bladder Management Systems filed on Jan.23, 2016, which claims priority to U.S. Provisional Application Ser. No.62/141,520 filed Apr. 1, 2015, U.S. Provisional Application Ser. No.62/231,854 filed Jul. 16, 2015, U.S. Provisional Application Ser. No.62/275,671 filed Jan. 6, 2016, and U.S. Provisional Application Ser. No.62/279,485, filed Jan. 15, 2016. This application is also a continuationin part of, and claims priority to U.S. National Phase application Ser.No. 15/545,903 to Herrera et al., entitled Bladder Management Systemfiled Jul. 24, 2017, which claims priority to PCT Application Serial No.PCT/US2016/014648 filed Jan. 23, 2016, which claims priority to U.S.Provisional Application Ser. No. 62/107,203, filed Jan. 23, 2015, U.S.Provisional Application Ser. No. 62/141,520, filed Apr. 4, 2015, U.S.Provisional Application Ser. No. 62/231,854, filed Jul. 16, 2015, U.S.Provisional Application Ser. No. 62/275,671, filed Jan. 6, 2016, andU.S. Provisional Application Ser. No. 62/279,485, filed Jan. 15, 2016.This application is also a continuation in part of, and claims priorityto U.S. application Ser. No. 15/721,096 to Herrera et al. entitledUrinary Prosthesis Systems filed on Sep. 29, 2017, which is a divisionalof, and claims priority to, U.S. application Ser. No. 15/419,948 (NowU.S. Pat. No. 9,775,698) entitled Urinary Prosthesis Systems and filedon Jan. 30, 2017, which is a Continuation in part of PCT ApplicationSerial No. PCT/US2016/014648 filed on Jan. 23, 2016, which claimspriority to U.S. Provisional Application Ser. No. 62/107,203, filed Jan.23, 2015. Each of the foregoing applications is incorporated herein byreference.

FIELD

This disclosure relates to devices, systems and methods that can be usedfor bladder management, such as an extended-use catheter, and devicesthat can connect to the extended use catheter in order to position it ina body and/or remove it from a body.

BACKGROUND

Many people suffer from lower urinary tract dysfunction, also known asneurogenic bladder. Neurogenic bladder can be defined as impairedurinary function due to neurological injury or disease, such as spinalcord injury (SCI). Current methods for managing neurogenic bladder andother chronic urinary retention disorders are to drain the bladder using(a) intermittent catheterization (IC), or (b) indwelling Foleycatheters. These methods, however, are associated with relatively highrates of urinary tract infection and genito-urinary (GU) injury, each ofwhich diminishes a patient's quality of life. Furthermore, because someindividuals with neurogenic bladder lack bladder sensation, and thuscannot accurately perceive bladder fullness, they are susceptible tobladder over-filling. This can result in urinary “accidents” and/orurinary reflux, and urinary reflux presents a risk of infection andtissue damage to the upper urinary tract.

To avoid these problems, individuals with neurogenic bladder on an ICprogram commonly rely on a timed catheterization schedule. This approachis imprecise and may lead to catheterization more frequently thannecessary, which can increase the risk of infection and GU injury.Therefore, it is desirable to provide an improved urinary prosthesisthat helps to alleviate one or all of the preceding problems.

SUMMARY

The present disclosure relates to devices, systems and methods forextended-use bladder management and controlling urinary function forhumans or other animals. The disclosed devices, systems, and methods maybe used for fluid flow control for other bodily organs as well, such askidneys, or draining abscesses or fluids from a body, and thedescription herein for bladder-control use is not limiting.

Disclosed is an extended-use catheter configured for being retainedinside of the body. The catheter can be used, for example, in the humanmale urinary tract. When in use, it is preferably positioned fullyinside of, and retained in, the urethra and bladder. In one embodiment,the catheter comprises an elongated tube having a wall with an outersurface, and a lumen through which fluid, such as urine, can pass.Positioned on, or formed as part of, the tube wall is a retainer portionwith a cross-sectional area greater than the cross-sectional area of theouter surface of the tube wall. When the catheter is properly positionedin the urinary tract, the retainer portion is positioned in the bulbarurethra, where it aids in the proper positioning of the catheter andhelps prevent the catheter from inadvertently moving forward orbackward.

A catheter according to this disclosure could be periodically inserted,removed, and replaced by the user without medical assistance or the aidof another individual, which is convenient and saves time and medicalexpense. Such a catheter could remain in the body for days or weekswithout being removed, which alleviates the problem of catheterizationmultiple times per day.

The catheter preferably includes a valve, wherein the valve can beoperated to: (a) allow fluid to exit the proximal end of the catheter,where it can exit the body, or (b) prevent the flow of fluid out of theproximal end of the catheter. The valve is most preferably a magneticvalve controlled from outside of the body using a wireless controllerthat generates a wireless signal to the valve to open or close.

A catheter mating device configured to engage and move the catheter isalso disclosed and may be part of a system according to aspects of theinvention. The catheter mating device has a distal end and a proximalend. The distal end is configured to connect to the proximal end of thecatheter, and includes an apparatus moveable between: (a) a firstposition, wherein the apparatus is retracted, and (b) a second position,wherein the apparatus is expanded. When in the first position, theapparatus is configured to fit into the lumen (or a mating chamber ofthe catheter) at the proximal end of the catheter. Once placed in thelumen, the apparatus can be moved to its second position, wherein theapparatus expands until it presses against and engages the wall of thelumen (or inner wall of the mating chamber). That connects the cathetermating device to the catheter, and the catheter can then be pushed into,or removed from a body structure, such as a bladder and urethra by,respectively, pushing or pulling the catheter mating device. Thus, thecatheter mating device can be used to: (a) accurately place the catheterinside of a body, and/or (b) remove the catheter from a body.

The catheter may be configured to include one or more sensors, which maybe on, inside of, or embedded in material forming the catheter, orpartially or entirely within the lumen. The one or more sensors can beat any suitable location on the catheter, such as at a position wherethey are positioned in the bladder when the catheter is properlypositioned in the lower urinary tract of a human male. The one or moresensors could collect any relevant data, such as fluid pressure in thebladder, pH level of fluid, volume of urine in the bladder, and/oramount of blood or bacteria in urine. The one or more sensors couldcommunicate with other devices, such as CT scanners, ultrasound devices,x-ray machines, electronic data storage devices, computers, cell phones,the wireless controller, the catheter mating device and/or sensorsplaced in toilets. The data collected by the sensors could be stored,analyzed and/or transmitted by a device including software configuredfor these functions.

Because the catheter can remain in the body for long periods, a sensoron the catheter can gather and send data over the entire period thecatheter is in the body, as opposed to gathering data only at a specifictime, such as when a patent is at a doctor's office or hospital.

A catheter according to aspects of the invention could also include oneor more antennas to communicate with the one or more sensors, andtransmit data collected by the one or more sensors. The catheter couldhave a second lumen that includes one or more antennas and one or morecatheters.

As used herein, the term “user” means any person able to insert and/orremove a catheter as disclosed herein, and includes a patient, doctor,caregiver, and nurse. “Patient” means a person that uses a catheter asdisclosed herein in his/her body. “Lower urinary tract” referscollectively to the urinary bladder and urethra. “Extended use” means acatheter that can be used without having to remove it from the body morethan once every two days or longer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an exemplary catheter, with an open view at itsproximal end.

FIG. 1A is a cross-sectional view of the tube of the catheter of FIG. 1taken along lines 1A-1A.

FIG. 2 shows the catheter of FIG. 1 positioned in the lower urinarytract of a human male.

FIG. 3A is a side view of an exemplary embodiment of a catheter retainerportion according to aspects of the invention.

FIG. 3B is a cross-sectional view of the catheter retainer portion ofFIG. 3A taken along lines 3A-3A.

FIG. 3C is a side, perspective view of an exemplary embodiment of acatheter retainer portion according to aspects of the invention.

FIG. 3D is a side, perspective view of an alternative exemplaryembodiment of a catheter according to aspects of the invention that hasa plurality of retainer portions.

FIG. 3E is a side, perspective view of an exemplary embodiment of acatheter according to aspects of the invention that has a plurality ofretainer portions

FIG. 4 is a close-up, open view of the proximal end of the catheter ofFIG. 1 showing a valve.

FIGS. 4A-4C show the valve of FIG. 4 and components of the valve.

FIG. 5 is an exemplary embodiment of a wireless valve wirelesscontroller.

FIG. 6 is a top view of an exemplary catheter mating device.

FIG. 7 is an exploded view of the catheter mating device of FIG. 6.

FIG. 8 is a side, perspective, close-up view of the distal end of thestem of the catheter mating device of FIG. 6.

FIGS. 8A and 8B are front views of the distal end of the stem of thecatheter mating device of FIG. 6.

FIGS. 8C and 8D are partial, side views of the distal end of the stem ofthe catheter mating device of FIG. 6.

FIG. 9 is a top view of the catheter mating device of FIG. 6 (with theapparatus in its first, retracted position) being aligned with thecatheter of FIG. 1.

FIG. 10 is another top view of catheter mating device of FIG. 6 (withthe apparatus in its first, retracted position) being aligned with thecatheter of FIG. 1.

FIG. 11 is a side, open view of the catheter mating device of FIG. 6(with the apparatus in its first, retracted position) with its distalend positioned in the lumen at the proximal end of the catheter of FIG.1.

FIG. 12 is a side view of an exemplary catheter that has one or moresensors, with an open view at its proximal end.

FIG. 13 is a side view of an exemplary catheter having two lumens, withan open view at its proximal end.

FIGS. 14A and 14B are cross-sectional views of exemplary catheters withtwo lumens.

FIG. 15 shows the catheter mating device of FIG. 6 (with the apparatusin its second, expanded position) engaged with the catheter of FIG. 1.

FIG. 16 shows the catheter mating device of FIG. 6 being aligned withthe catheter of FIG. 1 when the catheter is positioned in the lowerurinary tract of a human male.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Extended-Use Catheter

Turning now to the Figures, wherein the purpose is to describe preferredembodiments and not to limit the scope of the invention, FIG. 1 shows anexemplary catheter 10 according to aspects of the invention. Catheter 10is an extended use catheter, and can be shaped and sized to beintroduced into, and retained in, the lower urinary tract of a humanmale. As shown in FIG. 2, catheter 10 can extend from the bladder 2050to a portion of the urethra 2600 distal to the prostate and distal tothe bulbar urethra. Catheter 10 as shown in FIG. 2 extends past theprostate and the external urinary sphincter. In a female anatomy, theretainer portion is preferably positioned within the urethra, betweenthe internal urethral orifice and the external urethral orifice. Theretainer portion can then be positioned such that it is in the urethrabetween the meatus and the external urethral sphincter. Catheter 10 ispreferably fully internal to the body once properly installed.

Turning to FIGS. 1 and 1A, catheter 10 can comprise a tube 12 with awall 12A having an outer surface 12B, a lumen 14 with a lumen wall 14A,a valve 100, a retainer portion 20, a proximal end 16 with a proximaltip 16A and an engagement chamber 16B, and a distal end 18 with openings18A and a distal tip 18B. The catheter tube 12, which is shown in crosssection in FIG. 1A, preferably has a circular cross-sectional shape, butcan be of any shape suitable for the intended use of catheter 10. Whenused in the lower urinary tract of a human male, as shown in FIG. 2,tube 12 preferably has an outer diameter (as measured across outersurface 12B) ranging from about 1 French (0.3 mm) to 20 French (6.6 mm),which is approximately the same as or less than the maximum expandeddimension of the urethra 2600. Wall 12 can have a hardness of any amountfrom: about 30 Shore A to 55 Shore D, or about 30 Shore A, or about 30to 50 Shore A, or about 20 to 50 Shore A, although any suitable hardnessfor the intended use of catheter 10 would suffice.

Lumen 14 may have any suitable cross-sectional geometrical shape (e.g.,circular (which is most preferred), oval, semi-circular, rectangular,triangular, trapezoidal, or crescent) and can have a cross-sectionalsurface area (which is the area inside of lumen wall 14A when viewed incross section) equivalent to the area of a 0.1 mm diameter circle tothat of a 5.5 mm diameter circle. If the cross-sectional shape of lumen14 is circular lumen 14 preferably has a diameter of any amount from:0.1 mm to 5.5 mm. Lumen 14 may also comprise different cross-sectionalareas along its length. For example, the cross-sectional area of thelumen may be greater where the valve 100 is positioned, and/or a greatercross-sectional area at the proximal end 16. Or, the lumen'scross-sectional area may be greater along its entire length distal tovalve 100.

Tip 16A can have an outer diameter greater than the diameter of theouter wall 12B. For example, tip 16A may have a diameter of 0.5 mm-1 mmgreater than outer wall 12B. The purpose of tip 16A having a slightlylarger diameter is so a user can locate it by touch (e.g., by pressingagainst the skin and feeling the ridge at tip 16A) when tip 16A ispositioned in the penile urethra.

An engagement chamber 16B can be at or near the proximal end 16 of thecatheter 10. The engagement chamber 16B can be located between theproximal tip 16A and the valve 100, or extend from proximal tip 16A tovalve 100 or a position proximal valve 100. The engagement chamber 16Bincludes a space configured to engage the apparatus 1172 as generallyshown in FIGS. 9-11 and described below. The engagement chamber 16B canhave an annular, cylindrical shape, with a circular cross-sectionalthough any suitable shape may be used. As shown, the engagementchamber 16B has a circular cross-sectional shape with a diameterpreferably form 0.1 mm to 5.5 mm. The engagement chamber 16B may have ahardness greater than the hardness of tube 12. For example, the hardnessmay be of any hardness between 10 Shore A to 55 Shore D harder than tube12, or 10 Shore A—20 Shore A harder, or 20 Shore A—50 Shore A harder, or50 Shore A—55 Shore D harder. A purpose for engagement chamber 16B beingharder than tube 12 is to better secure apparatus 1172 in engagementchamber 16B. It is not, however, required that catheter 10 have a matingchamber 16B. For example, apparatus 1172 could engage lumen wall 14A oranother structure.

As shown in FIGS. 1 and 2, distal end 18 and tip 18B are configured toenter the patient's body through the urethral orifice 2700, and into theurethra 2600 when catheter 10 is positioned inside the lower urinarytract. As shown in this embodiment, distal tip 18B is tapered, roundedand closed. The distal tip 18B can comprise a material with hardnessgreater than the hardness of wall 12A. Distal end 18 permits the inflowof bodily fluid, such as urine, from a bladder or other body part intolumen 14, which can be accomplished in any suitable manner. One or more(as shown, two) openings 18A permit bodily fluid, such as urine, toenter lumen 14. As shown, openings 18A are on opposite sides of tube 12,so if one opening 18A is blocked because it is positioned against bodytissue, the other opening 18A should still be unblocked. However, thereneed only be one opening, or there could be more than two openings, andthe openings could be of any suitable size, configuration or location sothey allow fluid, such as urine from the bladder, to enter lumen 14.

When catheter 10 is positioned in the lower urinary tract of a humanmale, the one or more openings 18A are positioned in the bladder 2500,as shown in FIG. 2.

Retainer Portion

The retainer portion 20 is positioned in the bulbar urethra 2300 whencatheter 10 is properly positioned in the lower urinary tract of a humanmale. Retainer portion 20 is configured to prevent the inadvertentmigration of catheter 10 either forward or backward once catheter 10 isproperly positioned in the body. If positioned in the bulbar urethra,the retainer portion 20 is blocked by the external sphincter to preventinadvertent retrograde migration, and blocked by the penile portion ofthe urethra 2600 to prevent inadvertent ante grade migration. Whensufficient pulling or pushing force is applied to catheter 10, retainerportion 20 compresses so that it can pass through the urethra 2600 whencatheter 10 is being removed from, or being placed in, the lower urinarytract.

Retainer portion 20 is preferably formed: (a) over or as part of wall12A of tube 12, or (b) as a separate part that has a passage, such aspassage 28 shown in FIG. 3B or passage 8430 shown in FIG. 3C, whereinpart of tube 12 is positioned snuggly in the passage. Each passage 28and 8430 has a dimension configured to receive part of tube 12 andenable retainer portion 20 to fit snuggly on tube 12. Retainer portion20 can comprise ribs, dimples, staples, or other structures on its outersurface to help retain it in the bulbar urethra or other body area.

As best seen in FIGS. 1 and 3A, the retainer portion 20 can comprise atop surface 22, proximal tapered surface 24, and a distal taperedsurface 26. The proximal tapered surface 24 can be tapered from the topsurface 22 to about the outer surface 12B of tube 12. The distal taperedsurface 26 can be tapered from the top surface 22 to about the outersurface 12A of tube 12. The retainer portion has a length as measuredalong the longitudinal axis X of catheter 10. In one embodiment theretainer portion 20 has a total length of any amount from about: 1 cm to10 cm, or 2 cm to 8 cm, or 3 cm to 7 cm, or 4 cm to 6 cm, and topsurface 22 has a length of any amount from about: 1 cm to 10 cm, orabout 10%, about 20%, about 30%, or about 40%, or about 50%, or about60%, or about 70%, or about 80%, or about 90%, or about 95%, or anyamount from about 5% to 95%, of the total length of retainer portion 20.

In an embodiment suitable for use in the lower urinary tract of a humanmale, the maximum cross-sectional area as measured inside of surface 22(and including the cross-sectional area of passage 28) or surface 8410(and including the cross-sectional area of passage 8430) is: (a) greaterthan the cross-sectional area of the external sphincter, (b) greaterthan the cross-sectional area of the penile urethra 2600, and (c)smaller than the cross-sectional dimension of the bulbar urethra 2300.The maximum cross-sectional area (as measured when retainer portion 20is not being compressed) may be 1.2 times larger, 1.5 to two timeslarger, three times as large, four times as large, five times as large,six times as large, seven times as large, eight times as large, ninetimes as large, ten times as large, or any amount from: 1.2 to fivetimes as large, or 1.5 to ten times as large, as the cross-sectionalarea measured inside the outer surface 12B of tube 12. The maximumcross-sectional area (as measured when retainer portion 20 is not beingcompressed) may be any amount from: (24 mm)²π to (25 mm)²π, (4 mm)²π to(25 mm)²π, or (6 mm)²π to (20 mm)²π, or (8 mm)²π to (16 mm)²π, or (10mm)²π to (15 mm)²π, or (12 mm)²π to (15 mm)²π, or (5 mm)²π to (10 mm)²π.In one embodiment the top surface 22 has a circular cross-sectionalshape and has a diameter of any amount from: 5 mm to 10 mm, or 5 mm to 7mm, or 4 mm to 8 mm, or 6 mm to 15 mm, or 8 mm to 15 mm, or 6 mm to 20mm, or 8 mm to 22 mm. The diameter of surface 12B (which is the outerdiameter of tube 12) can be about 2.0 mm to 6.0 mm, or 4.6 to 6.0 mm, orany amount from: 1.5 mm to 6.5 mm.

FIG. 3C shows alternate retainer portion 20′ comprising one or moremounds 8410 and one or more grooves 8420 formed in its outer surface8410. The retainer portion 20′ can comprise alternating grooves 8420 andmounds 8410. For example, the retainer portion 20′ can comprise fourgrooves 8420 and four mounds 8410 as shown in FIG. 3C. Thecross-sectional shape of the retainer portion could also symmetrical orasymmetrical, and be circular, cross-like, or any suitable shape for usewith catheter 10.

The catheter 10 may comprise two or more retainer portions 20A as shownin FIG. 3D for catheter 10′, or have any suitable number of retainerportions along wall 12, wherein the plurality of retainer portions couldbe of different shapes and/or sizes. For example, the catheter 10 cancomprise a first retainer portion 20A and a second retainer portion 20A,wherein (if catheter 10 is being used in the lower urinary tract of ahuman male) both are positioned in the bulbar urethra when catheter 10is positioned in a body. Retainer portions 20A would have respectivelengths suitable for fitting into a body area such as the bulbarurethra, for their intended use.

FIG. 3E shows a catheter 10B that has a plurality of retainer portions21, 21A, 21B, and 21C of different shapes and sizes. The retainerportions would have suitable shapes and sizes for fitting into one ormore body areas, such as the bulbar urethra.

Regardless of the structure or number of the retainer portion(s)utilized, any retainer portion can be comprised of solid material orinclude gas pockets. Each retainer portion should be atraumatic, and itpreferably has a relatively soft, atraumatic surface. Retainer portioncan be comprised of a flexible silicone and/or have a soft siliconesurface coating. The retainer portion preferably has a durometer of anyamount from: 1 to 40, or 5 to 30, or 10 to 25, or 15-25 Shore A. Theretainer portion is preferably compressible. For example, the retainerportion can comprise a material that compresses to pass throughcross-sectional areas smaller than the maximum cross-sectional area ofthe retainer portion. When used in the lower urinary tract of a humanmale, the retainer portion should compress to at least a dimension sothat it can be pushed or pulled through the maximum expanded dimensionof urethra 2600, which could be about 6 mm to 12 mm, or about 10 mm. Theretainer portion expands once it is no longer restricted. When used inthe lower urinary tract of a human male, the retainer portion iscompressed when it is pulled through the urethra 2600 and expands onceit enters the bulbar urethra 2300.

In some embodiments, the retainer portion may be compressed to about80%, 75%, 70%, 60%, 50%, 40%, 30%, 25%, 20%, 10%, or any amount fromabout 10%-80% of the maximum cross-sectional area. The retainer portion20 is compressed to any such amount when a total force is appliedsubstantially equally to the outer surface of the retainer portion atthe maximum cross-sectional area in an amount of 2 lbs., 3 lbs., 4 lbs.,5 lbs., 6 lbs., 7 lbs., 8 lbs., 9 lbs., 10 lbs., 11 lbs., 12 lbs., 13lbs., 14 lbs., 15 lbs., 16 lbs., 17 lbs., 18 lbs., 19 lbs., 20 lbs., orany force within the range of: 1-10 lbs., 2-20 lbs., or 0.5-5.0 lbs.

Valve

The valve 100 is preferably configured to restrict, or allow, fluid flowfrom the bladder 2000 (or other body part) out of the proximal end 16 ofcatheter 10. In the embodiment shown, the valve 100 is located in lumen14 between the proximal end 16 and the retainer portion 20, although thevalve 100 can be positioned at any suitable location in the lumen 14, orat the distal end 18 or proximal end 16 of catheter 10, as long as thevalve can open to allow, and close to prevent fluid flow out of proximalend 16. As shown in this embodiment, the valve 100 is a magnetic valve,and wireless controller 6000 (described below) can be placed on or nearvalve 100 from outside of the patient's body to operate valve 100.

The valve 100 preferably comprises a cylindrical body. As shown in FIG.4, the valve 100 includes a housing 5050, a screw portion 5100, a valvemagnet 5150, a valve tip 5200, a spindle 5250, and an alignment tube5300. The housing 5050 can comprise a cylindrical body. The screwportion 5100 can comprise a threaded body. The valve tip 5200 can beconnected to the spindle 5250. The valve tip 5200 can be configured toopen and close the valve. For example, the valve tip 5200 can comprise aconical surface corresponding to a seating structure of the valveopening 5400.

The screw portion 5100 can be movable inside the housing 5050. Thehousing 5050 and the screw portion 5100 can be in a threaded connection.The magnet can be connected to the screw portion 5100 and the spindle5250. By moving the magnet 5150, the valve 100 can open and close. Forexample, the magnet 5150 can be moved by using an wireless controller600 (described below) to open and close the valve 100, such as byspinning magnet 5150, in order to activate the valve 100 and facilitateand/or control fluid flow. The valve 100 and the wireless controller6000 can be configured to allow the user to increase or decrease theflow rate of the urine from the bladder 2500 by the wireless controller600 signaling the valve 100.

If valve 100 is a magnetic valve, as shown in this embodiment, when itis operated it pumps fluid, rather than simply allowing fluid to flow asa result of fluid pressure in the bladder 2500 or other body structurein which distal end 18 is positioned. Using the bladder 2500 as anexample, by pumping fluid the bladder is more completely emptied, whichcan lead to relieving the bladder fewer times over a given period oftime. Alternatively, the valve could be any structure that can beoperated to (a) prevent the passage of fluid out of proximal end 16, and(b) allow fluid to flow past proximal end 16.

Catheter Mating Device

A system according to the invention can comprise a catheter 10 and acatheter mating device 1000, wherein the catheter mating device 1000 andcatheter 10 are each configured to connect to one another so thatcatheter 10 can be moved by moving the catheter mating device 1000. Thecatheter mating device 1000 can be used to place the catheter 10 into apatient's body, and to remove the catheter 10 from the patient's body.The catheter mating device 1000 comprises a stem 1150 that includes: (a)a tube 1152 having an outer surface (or external wall) 1154 and a lumen1162, (b) an inner cylinder 1160 having a distal end 1160A and aproximal end 1160B connected to a control 1520, and (c) a distal end1170 with apparatus 1172.

The apparatus 1172 is a structure that operates mechanically to connectthe stem to the proximal end of the catheter, thus connecting thecatheter mating device 100 to catheter 10. Apparatus 1172 has a first,retracted position, wherein it can fit inside of the proximal end 16 oftube 12, and a second, expanded position, wherein it engages proximalend 16 and connects catheter mating device 100 to catheter 10.

In this embodiment, the apparatus 1172 comprises tips 1174 that areconfigured to be positioned inside proximal end 16 (such as inside ofengagement chamber 16B) when tips 1174 are in their first, retractedposition and have a first distance between them (which may be zerodistance because tips 1174 may touch when in the first, retractedposition) as best seen in FIGS. 9-11. Tips 1174 can be moved to theirsecond, expanded position in which they have a second distance betweenthem that is larger than the first distance. In the second, expandedposition, tips 1174 engage the inner wall of engagement chamber 16B,which connects catheter 10 to catheter mating device 1000. Once engaged,the catheter 10 can be moved through the urethra 2600, as shown best inFIG. 15, by using the catheter mating device 1000 either to push andadvance, or pull and retract, the catheter 10.

When in their second, expanded position, the tips 1174 (as measured whenthey are not restricted by a structure, such as the inner wall of matingchamber 16B or another structure), can have a maximum outer distanceacross them that is the same, or greater than, the diameter of matingchamber 16B (or other inner portion of catheter 10, such as lumen 14,because mating chamber 16B need not be used) in order for tips 1174 tocreate an interference fit against the inner wall of mating chamber 16B(or other structure). The tips 1174 can be comprised of any suitablematerial, such as a plastic, metal, or a thermoplastic elastomer.

In some embodiments, the tips 1174 at distal end 1170 form a taperedconfiguration such that they facilitate proper alignment of the tips1774 and engagement chamber 16B so that tips 1774 can be received insideof chamber 16B (or other structure of catheter 10, such as lumen 14).Tips 1174 may have rounded end portions 1175 that assist in engagingproximal end 16.

The catheter mating device 1000 in this embodiment comprises a cylinder1160 positioned inside of outer tube 1152. The cylinder 1160 is operatedto move from a retracted position to an extended position. When cylinder1160 is in its extended position (as shown in FIGS. 8, 8B, and 8D), thecylinder 1160 moves between the tips 1174 and pushes them open to theirsecond, extended position. When cylinder 1160 is in its retractedposition (as shown in FIGS. 8, 8A, 8C, and 9-11) tips 1174 are in theirfirst, retracted position. The cylinder 1160 may be comprised of anysuitable material, such as ABS or PTFE, and preferably has a tapereddistal end 1164.

A user may operate the catheter mating device 1000 by moving the control1520 to its second position, which move the apparatus 1172 to itssecond, expanded position, and by moving the control 1520 to its firstposition, in which the apparatus 1172 either moves to, or is moved toits first, retracted position. In the embodiment shown, control 1520 isa slide switch directly or indirectly connected to cylinder 1160. Whencontrol 1520 is in its first position, the cylinder 1160 is in itsfirst, retracted position. When control 1520 is moved to its secondposition, cylinder 1160 is moved to its second, extended position,wherein it moves between tips 1174 and pushes them open to their second,expanded position.

Although tips 1174 are shown as the apparatus 1172, other structuresthat can be mechanically expanded (as opposed to expanding utilizing gasor liquids) may be used. For example, there may more than two tips thatare expanded in the manner described herein. Or, the tips or otherstructures may be expanded in any suitable manner. Alternatively, thetube 1152 of the stem 1150 could function as an outer sheath, and theapparatus could be attached to the cylinder 1160. In that example, theapparatus could be a metal mesh tube. Such an apparatus would be in itsfirst, retracted position when contained inside of the tube 1152. Thetube would be connected to the control 1520 and pulled back to exposethe apparatus when the control 1520 is moved proximally (i.e., away fromthe catheter 10). That would permit the metal-mesh tube to automaticallyexpand to its second, expanded position to engage proximal end 16. Or,utilizing the same structure, the cylinder 1160 including the apparatuscould be connected to the control. In that case, a user could advancethe cylinder 1160 and metal mesh tube out of the tube 1152, and themetal mesh tube would automatically expand to its second, expandedposition. Alternatively, the stem could comprise an apparatus that is aflexible tube (comprised of rubber or flexible plastic) with one end ofthe tube connected to a first sleeve and another end connected to asecond sleeve. The first sleeve and second sleeve would be coaxial andat least one could move relative the other. A user could then manipulateone or both of the sleeves to compress the tube causing it to bulge,i.e., expand in the center, and engage the inner wall of the proximalend 16 (which could be engagement chamber 16B) of catheter 10.

The stem 1150 in this embodiment has a length configured to enable auser to place catheter 10 in the urinary tract using the catheter matingdevice 1000. For example, in this embodiment stem 1150 may have alengths (a) greater than the length of the penile urethra of a patient,(b) less than or equal to the length as measured from the membranousportion to the urethral orifice of a patient, and/or (c) less than thelength of the penile urethra of a patient. In some embodiments, the stem1150 is about 10 cm to 26 cm in length. Stem 1150 can include a fluidopening 1162 that is configured to allow fluid flow from the catheter 10to pass through the lumen 1164 of stem 1150 and out of the proximal end1152A of tube 1152, where the fluid can be collected or disposed, orpass through housing 1500 to be collected or disposed.

Housing

The catheter retainer portion 1000 can have a handle (or housing) 1500at its proximal end. Housing 1500 may house a portion of the stem 1150and/or cylinder 1160, and includes a control 1520. The housing 1500 iscomprised of any suitable material such as PVC or other plastic. Housing1500 has body portion 1500A, which can be formed of two connectedportions 1550 and 1580 as shown in FIG. 7. Body portion 1500A has adistal end 1502, a proximal end 1504, and a cavity 1506. An opening1510, which communicates with cavity 1506, is in surface 1588. A control1520 is positioned in cavity 1506 and extends through opening 1510 whereit can be accessed by a user.

As shown, control 1520 is a slide switch that can be moved from a first(proximal) position to a second (distal position). Control 1520 has aridge 1522 that can be pushed by a user's finger, a body portion 1524that extends through opening 1510, and a base 1526 positioned in cavity1506. Fasteners 1528 extend through apertures 1530 to retain control inhousing 1500.

In the embodiment shown, cylinder 1160 is connected to control 1520. Auser can move switch 1520 in a distal direction to push cylinder 1160 toits extended position, wherein the cylinder 1160 moves the apparatus toits second, expanded position. A user can move switch 1520 in a proximaldirection, wherein the cylinder 1160 moves to its retracted positionaway from the apparatus 1172 and the apparatus moves to its first,retracted position. Although a manual slide switch is described herein,control 1520 could be any structure that can operate to directly orindirectly move the apparatus to its second, expanded position.

The proximal end 1152A of tube 1152 is retained inside of cavity 1506.If fluid enters lumen (or passageway) 1164 it exits the proximal end1152A, and can flow through housing 1500, where it exits opening 1504Aat proximal end 1504. This allows for relatively easy collection ordisposal of fluid from the body in which catheter 10 is positioned. Inone embodiment, the stem 1150 has a length of about 10 cm to 26 cm.

Materials

The catheter 10 and the stem 1170 of catheter mating device 1000 are,respectively, constructed in a shape and of a material that is conducivefor their intended use. For example, the catheter 10 and stem 1170 maybe constructed of any material or materials suitable for catheters usedin the body (such as PVC, latex, silicone, polyurethane or any suitableblend of these materials).

Packaging and Use

The catheter mating device 1000 and the catheter 10 can be carried in asterilized pouch. A user may open the pouch comprising a catheter 10 andthe catheter mating device 1000 and insert the catheter 10 into thelower urinary tract, and could use catheter mating device 1000 beforeinserting the catheter 10 into orifice 2700 of urethra 2600.

Wireless Controller

Urine in the bladder (or fluid from another area in the body) can bevoided when the user utilizes an external wireless controller 6000(shown in FIGS. 2 and 5) to operate the valve 100 and allow urine totravel through the lumen 14, past proximal end 16, and out of catheter10. As shown in FIG. 5, the wireless controller 6000 can comprise anwireless controller magnet 6050, a power source 6100, an electroniccircuitry 6150, and one or more inputs 6200, 6250. In some embodiments,the one or more inputs 6200, 6250 can comprise a first input to open thevalve 100 and a second input to close the valve 100. The wirelesscontroller comprises two or more input modes, such as a close mode, anopen mode, and an off mode. The valve 100 is closed (or off) when thewireless controller 6000 is in its close mode, and is open (or inoperation) when the wireless controller is in its open mode. The valve100 can remain closed or remain opened when the wireless controller 6000is in its off mode. In some embodiments, the circuitry 6150 can comprisesoftware configured to automate the process of controlling fluid flowfrom bladder. A user can place the wireless controller 6000 near thevalve 100, e.g., on the skin of the patient between the scrotum and theshaft of the penis. The user may press the input 6200 to operate themagnet 6050.

Sensors and Data Collection

As shown in FIG. 12, the catheter 10D can include one or more sensors2000 configured to transmit data from the patient's body. In all otherrespects, catheter 10′ is the same as catheter 10, described above. Asused herein, any sensor used with a catheter according to the inventionis referenced by numeral 2000. Thus, one or more sensors 2000 refers toa single sensor and a plurality of sensors. The data can comprise one ormore of: fluid pressure of urine in the bladder and/or urethra, volumeof fluid in the bladder, temperature of fluid in the bladder and/orurethra, acidity of fluid in the bladder and/or urethra, bacteria typeand quantity of fluid in the bladder and/or urethra, chemicalcomposition of fluid of fluid in the bladder and/or urethra, fluid flowduring emptying of the bladder when valve 100 is open, or actuated. Oneor more sensors 2000 as described in this disclosure are of a type knownto those skilled in the relevant art, although the claims are notlimited to presently-known sensors. One or more sensors 2000 on orinside of catheter 10D would have basically consistent sensor locationand extended sensors measurements within the body to better monitorpatient conditions, without having sensors taken out of the body.

The one or more sensors 2000 can be placed at any suitable location oncatheter 10D. For example, one or more sensors 2000 can be placed on ornear the distal tip 18 of catheter 10D, in which case one or moresensors 2000 would be positioned in the bladder if catheter 10D isconfigured for use in the lower urinary tract of a human male. Acatheter 10D could comprise different inner diameters can include adiameter in which a sensor 2000 would fit, such that the sensor isretained within lumen 14 without preventing fluid flow through thelumen. For example, a sensor 2000 could be distal to openings 18A. Theouter wall 12A of the tube 12 would then prevent sensor 2000 fromcontacting body tissue or fluid. One or more sensors 2000 may bepositioned on or in retainer portion 20.

In one embodiment, one or more sensors 2000 can determine the pressureof urine within the bladder and send a signal to a processor that sendsthe information to a computing device, or the one or more sensors 2000could send data directly to the computing device. The computing device,which can be any device, such as a PC or other computer, cell phone,dedicated catheter device, the wireless controller, or the cathetermating device, can have software that determines whether and when fluid(such as urine) needs to be drained from the bladder. The computingdevice can notify the user in any manner to drain urine from his/herbladder. In some embodiments, the one or more sensors 2000 can be usedto determine when urine has been sufficiently drained from the bladder,such as by determining that the pressure level within the bladder hasdropped below a certain level. This information can be used to close thevalve 100 and halt the flow of urine from leaving the bladder. In someembodiments, the one or more sensors 2000 can include acoustics todetermine the volume of urine in the bladder. Different types of sensorscan be placed in or on the catheter 10 to determine metrics related tothe health of areas of the body, such as bladder health.

In some embodiments, a sensor 2000 can be configured to detect the flowrate of urine through the valve 100. For example, a catheter system 10Dcan comprise software configured to detect the flow rate of urinethrough the valve 100 by measuring the electric current draw of thevalve motor by wireless controller 6000. The catheter system 10D cancomprise an external computing device comprising a memory in wirelesscommunication (either intermittently or continuously) with theelectronic circuitry 6150 of wireless controller 6000 to record storeand/or transmit data measured by one or more sensors 2000.

In some embodiments, one or more sensors 2000 can function without apower source. By constructing the sensor in a specific manner theexternal unit can observe changes in the resonant frequencycharacteristics.

The data collected by one or more sensors 2000 can be stored, analyzed,and/or transmitted via software resident on a device outside of the bodyin which one or more sensors 2000 is positioned. The software mayutilize machine-learning algorithms to predict and interpret themeasurements.

The sensor can be configured to change its mechanical properties (e.g.size or shape) based on pressure changes inside the bladder. The usercan use an external device to detect changes in mechanical properties ofthe sensor by, for example, sending and/or receiving magnetic orelectronic signals.

In another embodiment shown in FIG. 13, catheter 10E has lumen 14 asdescribed herein, and a second lumen 14′. In all other respects,catheter 10E is the same as previously described catheter 10D. Secondlumen 14′ can house one or more antennas 2002 that communicate in anysuitable manner with the one or more sensors 2000 and with one or moreexternal devices, such as a transducer or external computer device.Antennas 2002 can send data from one or more sensors 2000 to one or moreexternal devices and signals from one or more external devices to any ofthe one or more sensors 2000. Antennas 2100 can have a power source2004. One, some, or all of the one or more sensors 2000 may be partiallyor totally in second lumen 14′.

Signal Transmission

One or more sensors 2000 can utilize basic wireless transmissionprotocol to send data to a computing device. This can be accomplishedutilizing to Bluetooth, 802.11 WiFi, SONAR, UltraSound, MedRadio, orother wireless communications protocols. For example, the sensors can beconfigured to interface with CT, ultrasound, x-ray, and/or electronicdata storage devices.

One or more sensors 2000 can comprise parts configured to interfaceand/or communicate with different products. For example, one or moresensors 2000 can be configured to interface with Amazon Echo® or GoogleHome®. One or more sensors 2000 could also be configured to interfacewith patient databases in hospitals or elsewhere. Information providedby a sensor 2000 may be formatted as desired. For example, analog datarelated to movement may be converted (using an analog to digitalconverter, for example) to a digital format, and subsequently formattedinto a data packet including a data header followed by one or more datavalues.

Any amount of data can be transmitted in any manner. For example, datafrom one or more sensors 2000 can be transmitted to another device asthe data is measured, or data can be stored (such as in a memory storagedevice) for a period of time before being transmitted to another device.In some cases, for example, it may be more efficient to transmit blocksof data at once rather than initiating communication with another deviceeach time data is available. In other cases, a device may be out ofrange or otherwise unavailable to receive the data from one or moresensors 2000. The data can also be stored for any desired length oftime, and/or until a particular event occurs. For example, the datacould be stored by one or more sensors 2000 until the catheter matingdevice 1000 is connected to catheter 10′ or 10″, or until wirelesscontroller 6000 is operated. Data could also be transmitted by one ormore sensors 2000 to any device, such as the wireless controller 6000,catheter mating device 1000, or a cell phone. The data could betransmitted to such a device when the device is within a given range ofone or more sensors 2000 (and hence a given range of the antenna(s)2002, if utilized).

Data can also be deleted when a data record in a sensor 2000 exceeds apredetermined storage time, and/or the oldest data record is deletedfirst after a predetermined storage size limit has been reached.

External Computer Device

The catheter system 1000 can comprise a computing device external to thepatient's body. The external computing device may comprise a memorywirelessly connected to the electronic circuitry 6150 to receiveoperational parameters of the lower urinary tract. In some embodiments,the computing device can have a software which can be used to interpretdata gathered the one or more sensors 2000. For example, one or moresensors 2000 may be a pressure sensor and the computing device cananalyze data pressure received from the sensor 2000 be used to alert auser about when the user's bladder is likely to contract and void.

NON-LIMITING EXAMPLES OF PREFERRED EMBODIMENTS Example 1

A catheter system comprising:

-   -   (a) a catheter comprising (i) a tube, the tube having (A) a wall        with an outer surface, the outer surface having a first        cross-sectional area, (B) a lumen, (C) a distal end with one or        more openings in communication with the lumen, and (D) a        proximal end with an opening in communication with the        lumen, (ii) a valve that is operated to be in (A) a closed        configuration, wherein fluid does not flow out of the proximal        end, or (B) an open configuration in which fluid does flow out        of the proximal end; and (iii) a retainer portion between the        distal end and the proximal end, the retainer portion having a        maximum cross-sectional area at least twice as great as the        first cross-sectional area; and    -   (b) a catheter mating device comprising: a stem having a        proximal end and a distal end; wherein the distal end includes        an apparatus having (i) a first configuration with a first        distal cross-sectional area, and (ii) a second configuration        with a second distal cross-sectional area that is greater than        the first distal cross-sectional area; the apparatus being        configured to be received in the proximal end of the catheter        when in its first configuration, and configured to engage the        proximal end of the catheter when in its second configuration.

Example 2

The catheter system of example 1, wherein the retainer portion has amaximum cross-sectional area that is 3-5 times greater than the firstcross-sectional area.

Example 3

The catheter of example 1, wherein the retainer portion has a maximumcross-sectional area that is 1.5-3 times larger than the firstcross-sectional area.

Example 4

The catheter system of any of examples 1-3, wherein the retainer portionhas a length and the maximum cross-sectional area is at a center of thelength.

Example 5

The catheter system of any of examples 1-4, wherein the retainer portionhas a length and the maximum cross-sectional area is along part of thelength.

Example 6

The catheter system of any of examples 1-3, wherein the retainer portionhas a top surface and the maximum cross-sectional length along theentire top surface.

Example 7

The catheter system of any of examples 1-6, wherein the length of theretainer portion is between 1 cm and 10 cm.

Example 8

The catheter system of any of examples 1-7, wherein the maximumcross-sectional area is between (4 mm)²π and (25 mm)²π.

Example 9

The catheter system of any of examples 1-7, wherein the retainer portionhas a circular cross-section at its maximum cross-sectional area, and adiameter of between 5 mm and 10 mm at the maximum cross-sectional area.

Example 10

The catheter system of any of examples 1-9, wherein the retainer portionhas a hardness of between 1 and 40 Shore A.

Example 11

The catheter system of any of examples 1-10, wherein the wall of thecatheter has a hardness of between 30 Shore A and 55 Shore D.

Example 12

The catheter system of any of examples 1-11, wherein the retainerportion is comprised of silicone.

Example 13

The catheter system of any of examples 1-12, wherein the retainerportion is positioned between the valve and the distal end.

Example 14

The catheter system of any of examples 1-12, wherein the retainerportion comprises one or more of grooves and mounds.

Example 15

The catheter system of any of examples 1-14 that is configured to becompletely retained inside of a urinary tract of a male human.

Example 16

The catheter system of any of examples 1-15, wherein the retainerportion extends outward from the outer surface of the wall.

Example 17

The catheter system of any of examples 1-16, wherein the retainerportion is configured to be compressed to have a maximum cross-sectionalarea of 0.3 mm to 8.0 mm when moved through a penile urethra.

Example 18

The catheter system of any of examples 1-17, wherein at least part ofthe retainer portion is configured to be positioned within the bulbarurethra of the patient when the catheter is positioned inside a urinarytract of a human male.

Example 19

The catheter system of any of examples 1-18, wherein the retainerportion is positioned on the tube.

Example 20

The catheter system of example 19, wherein the retainer portion includesa passage therethrough and part of the tube is positioned in thepassage.

Example 21

The catheter system of example 1, wherein the retainer portion has (a) adistal section that has (a) a smaller cross-sectional area than themaximum cross-sectional area, and (b) a proximal section that has asmaller cross-sectional area than the maximum cross-sectional area.

Example 22

The catheter system of any of examples 1-21, wherein the valve is amagnetic valve.

Example 23

The catheter system of any of examples 1-22, wherein the valve ispositioned in the lumen.

Example 24

The catheter system of any of examples 1-23 that further includes anengagement chamber at the proximal end, wherein the engagement chamberis about 10 Shore A to 55 Shore D harder than the wall.

Example 25

The catheter system of any of examples 1-23 that further includes anengagement chamber that has a diameter that is the same as a diameter ofthe lumen.

Example 26

The catheter system of any of examples 1-25 that further includes one ormore sensors on or in the catheter.

Example 27

The catheter system of example 26 comprising a sensor housing, whereinthe one or more sensors are positioned inside of the sensor housing.

Example 28

The catheter system of example 26 wherein the one or more sensors arepositioned inside of the lumen.

Example 29

The catheter system of example 26, wherein the one or more sensors arepositioned in a bladder when the catheter is positioned in a lowerurinary tract of a human male.

Example 30

The catheter system of example 26, wherein the catheter comprises adistal tip and at least a portion of the one or more sensors ispositioned inside of the distal tip.

Example 31

The catheter system of example 26, wherein the one or more sensors arepositioned at least partially in the lumen.

Example 32

The catheter system of any of examples 26-31 that has one sensor.

Example 33

The catheter system of any of examples 26-31 that has a plurality ofsensors.

Example 34

The catheter system of any of examples 26-33, wherein the one or moresensors are configured to collect data of the patient, the datacomprising one or more of: fluid pressure inside of the bladder, fluidvolume inside of the bladder, temperature inside of the bladder, acidityof urine, bacteria level and type in urine, chemical composition ofurine, motion of the patient, location of the patient, and fluid flowwhen emptying the bladder.

Example 35

The catheter system of any of examples 1-34, wherein the catheter matingdevice further includes a housing connected to the proximal end of thestem.

Example 36

The catheter system of example 35, wherein the proximal end of the stemis positioned inside of the housing.

Example 37

The catheter of any of examples 1-36, wherein the stem has an internalpassageway configured to the transport bodily fluid.

Example 38

The catheter system of example 37, wherein the internal passageway isinside of an external wall.

Example 39

The catheter system of example 38, wherein the external wall istransparent or translucent.

Example 40

The catheter system of example 37, wherein the internal passageway iscoaxial with the external wall.

Example 41

The catheter system of example 35, wherein the housing includes acontrol having a first position and a second position, and the distalend of the stem is in its first position when the control is in itsfirst position, and the distal end of the stem is in its second positionwhen the control is in its second position.

Example 42

The catheter system of example 41, wherein the control is a slide buttonon an outside surface of the housing, the slide button moveable betweenthe first position of the control and the second position of thecontrol.

Example 43

The catheter system of example 42, wherein the slide button is connectedto the cylinder.

Example 44

The catheter system of any of examples 35, 36 or 41-43, wherein thehousing includes a cavity, a housing proximal end and a housing distalend, and the housing proximal end is open to the cavity, and the housingproximal end has an opening through which fluid can pass.

Example 45

The catheter system of any of examples 35, 36 or 41-44, wherein thehousing is comprised of plastic.

Example 46

The catheter system of any of examples 35, 36 or 41-45, wherein thehousing includes an opening in one side, wherein the openingcommunicates with the cavity and the control is positioned in theopening.

Example 47

The catheter system of any of examples 1-46, wherein the tube has adurometer of between 35 Shore A and 90 Shore D.

Example 48

The catheter system of any of examples 1-47, wherein the apparatuscomprises a plurality of tips moveable from the first position to thesecond position.

Example 49

The catheter system of example 48, wherein the apparatus comprises twotips.

Example 50

The catheter system of example 49, wherein the tips move apart and intothe second position when the control is moved to its second position.

Example 51

The catheter system of example 48 that further includes a cylinderattached to the control, and the cylinder is movable between a between aretracted position and an extended position, wherein the cylinder in itsextended position contacts the tips and moves apart and into the secondposition, when the control is in its second position.

Example 52

The catheter system of example 51, wherein the cylinder in its retractedposition does not contact the tips and the tips are in their firstposition, when the control is in its first position.

Example 53

The catheter system of any of examples 51-52, wherein the cylinder has adurometer of between 60 Shore A and 90 Shore D.

Example 54

The catheter system of any of examples 1-53, wherein the distal end ofthe stem has a tip of a durometer of 5-65 Shore A greater than thedurometer of an outer tube of the stem.

Example 55

The catheter system of any of examples 1-54 that further includes anwireless controller that activates the valve.

Example 56

The catheter system of any of examples 26-34, further comprising anexternal computing device configured to process and store patient data,wherein the sensors are configured to wirelessly transmit data to theexternal computing device.

Example 57

The catheter system of example 56, wherein the external computing deviceis wirelessly connected to the valve and the valve is configured toactuate based on a command by the external computing device.

Example 58

The catheter system of any of examples 26-34 that further includes oneor more antennas, wherein the antennas are configured to transmit datareceived from the one or more sensors.

Example 59

The catheter system of any of examples 26-34, wherein the catheterincludes a second lumen and the one or more antennas are positioned inthe second lumen.

Example 60

The catheter system of example 56 that further includes one or moreantennas, wherein the antennas are configured to transmit data receivedfrom the one or more sensors to an external computing device.

Example 61

The catheter system of example 58, wherein the one or more antennas havea power source positioned in the catheter.

Example 62

The catheter system of any of examples 1-62, wherein the power source isa battery.

Example 63

The catheter system of example 1 that includes a plurality of retainerportions.

Example 64

The catheter system of example 63, wherein at least one of the pluralityof retainer portions has a different size than the other of theplurality of retainer portions.

Example 65

The catheter system of example 63, wherein at least one of the pluralityof retainer portions has a different shape than the other of theplurality of retainer portions

Example 66

A catheter comprising:

-   -   (a) a tube, the tube having (i) a wall with an outer surface,        the outer surface having a first cross-sectional area, (ii) a        lumen, (iii) a distal end with one or more openings in        communication with the lumen, and (iv) a proximal end with an        opening in communication with the lumen,    -   (b) a valve that is operated to be in (i) a closed        configuration, wherein fluid does not flow out of the proximal        end, or (ii) an open configuration in which fluid does flow out        of the proximal end; and    -   (c) a retainer portion between the distal end and the proximal        end, the retainer portion having a maximum cross-sectional area        at least twice as great as the first cross-sectional area.

Example 67

The catheter of example 66 that has a length of 173 mm to 223 mm.

Example 68

The catheter of example 66 or 67, wherein the retainer portion is 48 mmto 75 mm from a closest of the one or more openings in the distal end ofthe catheter.

Example 69

The catheter of any of examples 66-68, wherein the proximal end has aproximal tip and the distance from the proximal tip to the closest ofthe one or more openings is 159 mm to 197 mm.

Example 70

The catheter of any of examples 66-69, wherein the retainer portion hasa first end and a second end, and a first tapered portion at the firstend and a second tapered portion at the second end.

Example 71

The catheter of example 70, wherein the first tapered portion extendsfrom the outer diameter on the tube to the maximum diameter of theretainer portion, and the second tapered portion extends from the outerdiameter on the tube to the maximum diameter of the retainer portion.

Example 72

The catheter of example 71, wherein the first tapered portion has alength of 4 mm to 8 mm, and the second tapered portion has a length of10 mm to 25 mm.

Example 73

The catheter of any of examples 66-72 that further includes a secondlumen that includes one or more of: one or more sensors, and one or moreantennas.

Example 74

The catheter of any of examples 66-72 that further includes a secondlumen that includes an antenna.

Example 75

The catheter of example 74, wherein the second lumen has a length andthe antenna is at least half the length.

Example 76

The catheter of example 74, wherein the second lumen has a length andthe antenna is extends at least 70%, or 80%, or 90% of the length.

Example 77

The catheter of example 73, wherein the second lumen has a length equalto a length of the lumen.

Example 78

The catheter of any of examples 73-77, wherein the antenna is inelectrical contact with one or more sensors positioned on or in thecatheter.

Example 79

The catheter of example 78, wherein the antenna is physically connectedto the one or more sensors.

Example 80

The catheter of any of examples 73-79 that has a plurality of sensors.

Example 81

The catheter of example 73, wherein the one or more sensors arepositioned at one or more of: the distal end of the catheter, inside thelumen of the catheter, and in or on the retainer portion.

Example 82

The catheter of any of examples 66-81, wherein the retainer portion hasan outer surface, and one or more of dimples, depressions, and ribs onthe outer surface.

Example 83

The catheter of any of examples 66-82, wherein the proximal end has aproximal tip and a raised ridge at the proximal tip.

Example 84

The catheter of example 83, wherein the raised ridge has a diameter thatis 0.5 to 1.0 mm greater that a diameter of the tube.

Example 85

The catheter of any of examples 66-84 that further includes a matingchamber at the proximal end, the mating chamber being harder than thetube.

Example 86

The catheter of example 85, wherein the mating chamber has a durometerof between 45-65 Shore D.

Example 87

The catheter of example 85, wherein the mating chamber has a durometerof between 55-90 Shore D

Example 88

The catheter of example 85, wherein the mating chamber has a durometerof 55 Shore D.

Example 89

The catheter of any of examples 85-88, wherein the tube has a durometerof 50-65 Shore A.

Example 90

The catheter of any of examples 85-88, wherein the tube has a durometerof 60 Shore A.

Example 91

The catheter of any of examples 85-88, wherein the tube has a durometerof 10-30 Shore A.

Example 92

The catheter of any of examples 66-91, wherein the tube comprisessilicone.

Example 93

The catheter of any of examples 73 or 78-81, wherein the one or moresensors are configured to collect data of the patient, the datacomprising one or more of: fluid pressure inside of the bladder, fluidvolume inside of the bladder, temperature inside of the bladder, acidityof urine, bacteria level and type in urine, chemical composition ofurine, motion of the patient, location of the patient, and fluid flowwhen emptying the bladder.

Example 94

The catheter system of any of examples 1-65, wherein the catheter has alength of 173 mm to 223 mm.

Example 95

The catheter system of any of examples 1-65, wherein the retainerportion is 48 mm to 75 mm from a closest of the one or more openings inthe distal end of the catheter.

Example 96

The catheter system of any of examples 1-65, wherein the proximal endhas a proximal tip and the distance from the proximal tip to the closestof the one or more openings is 159 mm to 197 mm.

Example 97

The catheter system of any of examples 1-65, wherein the retainerportion has a first end and a second end, and a first tapered portion atthe first end and a second tapered portion at the second end.

Example 98

The catheter system of example 97, wherein the first tapered portionextends from the outer diameter on the tube to the maximum diameter ofthe retainer portion, and the second tapered portion extends from theouter diameter on the tube to the maximum diameter of the retainerportion.

Example 99

The catheter system of example 97, wherein the first tapered portion hasa length of 4 mm to 8 mm, and the second tapered portion has a length of10 mm to 25 mm.

Example 100

The catheter system of any of examples 1-65, wherein the catheterfurther includes a second lumen that includes one or more of: one ormore sensors, and one or more antennas.

Example 101

The catheter system of any of examples 1-65, wherein the catheterfurther includes a second lumen that includes one or more antennas.

Example 102

The catheter system of example 101, wherein the second lumen has alength and at least one antenna is at least half the length.

Example 103

The catheter system of example 101, wherein the second lumen has alength and the antenna is at least 70%, or 80%, or 90% of the length.

Example 104

The catheter system of example 73, wherein the second lumen has a lengthequal to a length of the lumen.

Example 105

The catheter system of any of examples 101-104, wherein the antenna isin electrical contact with one or more sensors positioned on or in thecatheter.

Example 106

The catheter system of example 105, wherein the antenna is physicallyconnected to the one or more sensors.

Example 107

The catheter system of any of examples 94-106 that has a plurality ofsensors on or in the catheter.

Example 108

The catheter system of example 107, wherein the one or more sensors arepositioned at one or more of: the distal end of the catheter, completelyor totally inside a lumen of the catheter, and/or on or in the retainerportion.

Example 109

The catheter system of any of examples 1-65 or 94-108, wherein theretainer portion has an outer surface, and one or more of dimples,depressions, and ribs on the outer surface.

Example 110

The catheter system of any of examples 1-65 or 94-109, wherein theproximal end has a proximal tip and a raised ridge at the proximal tip.

Example 111

The catheter system of example 110, wherein the raised ridge has adiameter that is 0.5 to 1.0 mm greater that a diameter of the tube.

Example 112

The catheter system of any of examples 1-65 or 94-111 that furtherincludes a mating chamber at the proximal end, the mating chamber beingharder than the tube.

Example 113

The catheter system of example 112, wherein the mating chamber has adurometer of between 45-65 Shore D.

Example 114

The catheter system of example 112, wherein the mating chamber has adurometer of between 55-90 Shore D.

Example 115

The catheter system of example 112, wherein the mating chamber has adurometer of 55 Shore D.

Example 116

The catheter system of any of examples 1-65 or 94-115, wherein the tubehas a durometer of 50-65 Shore A.

Example 117

The catheter system of any of examples 1-65 or 94-115, wherein the tubehas a durometer of 60 Shore A.

Example 118

The catheter system of any of examples 1-65 or 94-115, wherein the tubehas a durometer of 10-30 Shore A.

Example 119

The catheter system of any of examples 1-65 or 94-115, wherein the tubecomprises silicone.

Example 120

The catheter system of any of examples 1-65 or 94-119, wherein thecatheter further comprises one or more sensors configured to collectdata of the patient, the data comprising one or more of: fluid pressureinside of the bladder, fluid volume inside of the bladder, temperatureinside of the bladder, acidity of urine, bacteria level and type inurine, chemical composition of urine, motion of the patient, location ofthe patient, and fluid flow when emptying the bladder.

Example 121

The catheter system of any of examples 1-65 or 94-120, wherein the lumenhas a diameter of any amount from 0.1 mm to 5.5 mm.

Example 122

The catheter system of any of examples 1-65 or 94-121, wherein theretainer portion has a length of any amount from about: 1 cm to 10 cm,or 2 cm to 8 cm, or 3 cm to 7 cm, or 4 cm to 6 cm.

Example 123

The catheter system of any of examples 1-65 or 94-122, wherein theretainer portion has a top surface that has a length of any amount from:1 cm to 10 cm.

Example 124

The catheter system of any of examples 1-65 or 94-123, wherein theretainer portion has a top surface and the retainer portion has alength, and the length of the retainer portion is about 10%, or about20%, or about 30%, or about 40%, or about 50%, or about 60%, or about70%, or about 80%, or about 90%, or about 95%, of the length of theretainer portion.

Example 125

The catheter system of any of examples 1-65 or 94-124, wherein themaximum cross-sectional area of the retainer portion is any amount from:(4 mm)²π to (25 mm)²π, or (6 mm)²π to (10 mm)²π, or (5 mm)²π to (10mm)²π.

Example 126

The catheter system of any of examples 1-65 or 94-126, wherein theretainer portion at the maximum cross-sectional area can be compressed,by a force of an amount selected from the range of: 1 lb. to 10 lbs., or2 lbs. to 20 lbs.; wherein the force is applied substantially equally toan outer surface of the retainer portion at the maximum cross-sectionalarea compresses to any percentage of its original cross-sectional areafrom: 20%-75%.

Example 127

A catheter mating device comprising: a stem having a proximal end and adistal end; and wherein the distal end includes an apparatus having afirst configuration with a first cross-sectional area and a secondconfiguration with a second cross-sectional area that is greater thanthe first cross-sectional area.

Example 128

The catheter mating device of example 127 that further includes ahousing at the proximal end of the stem, the housing having a controlmoveable between a first position and a second position, wherein theapparatus is in its first, retracted position when the control is in itsfirst position, and the apparatus is in its second, expanded positionwhen the control is in its second position.

Example 129

The catheter mating device of example 128, wherein the control isconnected to a cylinder that is part of the stem.

Example 130

The catheter mating device of example 128 or 129, wherein the housingcomprises a distal end, a proximal end, a cavity, and an opening in theproximal end, wherein the opening communicates with the cavity.

Example 131

The catheter mating device of any of examples 127-130, wherein theapparatus comprises a plurality of tips moveable from the first,retracted position to the second, expanded position.

Example 132

The catheter mating device of example 131, wherein the apparatuscomprises two tips.

Example 133

The catheter mating device of any of examples 127-132, wherein theapparatus comprises a plurality of tips, and the cylinder is movablebetween a between a retracted position and an extended position, whereinthe cylinder in its extended position it contacts the tips and movesthem apart and into the second, expanded position.

Example 134

The catheter mating device of example 133, wherein the cylinder has aretracted position in which it does not contact the tips and the tipsare in their first position.

Example 135

The catheter mating device of any of examples 128-134, wherein theapparatus comprises a plurality of tips, and the tips move apart andinto the second, expanded position when the control is moved to itssecond position.

Example 136

The catheter mating device of any of examples 128-135, wherein thecontrol is a slide button on an outside surface of the housing, theslide button moveable between the first position of the control and thesecond position of the control.

Example 137

The catheter mating device of any of examples 128-136, wherein thehousing has a first side and a second side, and the second side has aside opening in communication with the cavity, wherein the control ispositioned partially in the cavity and extends through the side opening.

Example 138

The catheter mating device of any of examples 128-137, wherein theproximal end of the stem is positioned inside of the housing.

Example 139

The catheter mating device of any of examples 127-138, wherein the stemhas an internal passageway configured to the transport bodily fluidtherethrough.

Example 140

The catheter mating device of example 139, wherein the internalpassageway is inside of an external wall.

Example 141

The catheter mating device of example 140, wherein the internalpassageway is coaxial with the external wall.

Example 142

The catheter mating device of example 139 or 140 that further includes acylinder internal to the external wall and the internal passageway isbetween the cylinder and the external wall.

Example 143

The catheter mating device of any of examples 127-142, wherein thedistal end of the stem juxtaposed the apparatus has a durometer of 5-65Shore A greater than the durometer of the external wall.

Example 144

The catheter mating device of any of examples 139-143, wherein when theapparatus is in its second, expanded position, it defines an opening tothe internal passageway through which fluid can enter.

Example 145

The catheter mating device of any of examples 127-144 that is connectedto a catheter when the apparatus is in its second, expanded position.

Having thus described some embodiments of the invention, othervariations and embodiments that do not depart from the spirit of theinvention will become apparent to those skilled in the art. The scope ofthe present invention is thus not limited to any particular embodiment,but is instead set forth in the appended claims and the legalequivalents thereof. Unless expressly stated in the written descriptionor claims, the steps of any method recited in the claims may beperformed in any order capable of yielding the desired result. Nolanguage in the specification should be construed as indicating that anynon-claimed limitation is included in a claim. The terms “a” and “an”expressly used in the context of describing the invention (especially inthe context of the following claims) are to be construed to cover boththe singular and the plural, unless otherwise indicated herein orclearly contradicted by context.

What is claimed is:
 1. A catheter system comprising: (a) a cathetercomprising (i) a tube, the tube having (A) a wall with an outer surface,the outer surface having a first cross-sectional area, (B) a lumen, (C)a distal end with one or more openings in communication with the lumen,and (D) a proximal end with an opening in communication with the lumen,(ii) a valve that is operated to be in (A) a closed configuration,wherein fluid does not flow out of the proximal end, or (B) an openconfiguration in which fluid does flow out of the proximal end; and(iii) a retainer portion between the distal end and the proximal end,the retainer portion having a maximum cross-sectional area at leasttwice as great as the first cross-sectional area; and (b) a cathetermating device comprising: a stem having a proximal end and a distal end;wherein the distal end includes an apparatus having (i) a first,retracted configuration, (ii) a second, expanded configuration; theapparatus being configured to be received in the proximal end of thecatheter when in its first, retracted configuration, and configured toengage the proximal end of the catheter when in its second, expandedconfiguration; and (iii) a housing connected to the proximal end of thestem, wherein the housing includes a control having a first position anda second position, and the apparatus is in its first, retracted positionwhen the control is in its first position, and the apparatus is in itssecond, extended position when the control is in its second position. 2.The catheter system of claim 1, wherein the retainer portion has amaximum cross-sectional area that is 2-3 times greater than the firstcross-sectional area.
 3. The catheter system of claim 1, wherein theretainer portion has a maximum cross-sectional area that is 1.5-4 timeslarger than the first cross-sectional area.
 4. The catheter system ofclaim 1, wherein the retainer portion has a length and the maximumcross-sectional area is at a center of the length.
 5. The cathetersystem of claim 1, wherein the retainer portion has a length and themaximum cross-sectional area extends along part of the length.
 6. Thecatheter system of claim 1, wherein the maximum cross-sectional area isan area from: (24 mm)2π to (25 mm)2π, or (4 mm)2π to (25 mm)²π.
 7. Thecatheter system of claim 1, wherein the retainer portion is circular incross-section at its maximum cross-sectional area, and has a diameter of5 mm to 10 mm at the maximum cross-sectional area.
 8. The cathetersystem of claim 1, wherein the retainer portion has a hardness of anamount from: 1 and 40 Shore A, or 5-15 Shore A, or 10-20 Shore A, or5-15 Shore A, or 10-15 Shore A.
 9. The catheter system of claim 1,wherein the retainer portion is comprised of silicone.
 10. The cathetersystem of claim 1, wherein the retainer portion has an outer surface andcan be physically compressed to ½ or less of the maximum cross-sectionalarea when subjected to a compressive force evenly applied along theouter surface of the cross-sectional area of an amount from: 3-5 lbs.,or 2-4 lbs., or 2-6 lbs., or 4-6 lbs., or 5-10 lbs., or 7-10 lbs., or5-22 lbs.
 11. The catheter system of claim 1, wherein the retainerportion is configured to be compressed to have a maximum diameter of 0.3mm to 8.0 mm when moved through a penile urethra and to have a maximumdiameter of 4.0 mm to 15 mm when positioned in the bulbar urethra. 12.The catheter system of claim 1, wherein the retainer portion includes apassage therethrough and part of the tube is positioned in the passage.13. The catheter system of claim 1 that further includes one or moresensors on or in the catheter.
 14. The catheter system of claim 13,wherein the one or more sensors are positioned in a bladder when thecatheter is positioned in a lower urinary tract of a human male.
 15. Thecatheter system of claim 13, wherein the one or more sensors arepositioned at least partially in the lumen.
 16. The catheter system ofclaim 13, wherein the one or more sensors are configured to collect dataof the patient, the data comprising one or more of: fluid pressureinside of the bladder, fluid volume inside of the bladder, temperatureinside of the bladder, acidity of urine, bacteria level and type inurine, chemical composition of urine, motion of the patient, location ofthe patient, and fluid flow when emptying the bladder.
 17. The cathetersystem of claim 13 that further includes one or more antennas, whereinthe antennas are configured to transmit data received from the one ormore sensors.
 18. The catheter system of claim 13, wherein the catheterincludes a second lumen and the one or more antennas are positioned inthe second lumen.
 19. The catheter system of claim 1, wherein the stemhas an internal passageway configured to transport bodily fluid.
 20. Thecatheter system of claim 1, wherein the control is a slide button on anoutside surface of the housing, the slide button moveable between thefirst position of the control and the second position of the control.21. The catheter system of claim 1, wherein the apparatus comprises aplurality of tips moveable from the first, retracted position to thesecond, extended position.
 22. The catheter system of claim 21, whereinthe apparatus comprises two tips.
 23. The catheter system of claim 1,wherein the apparatus comprises a plurality of tips, and the tips moveapart and into the second, expanded position when the control is movedto its second position.
 24. The catheter system of claim 23 that furtherincludes a cylinder attached to the control, and the cylinder is in aretracted position when the control is in its first position and thecylinder is in an extended position when the control is in its secondposition, and the cylinder contacts the tips and moves them apart andinto the second, expanded position, when the cylinder is in its extendedposition.
 25. A catheter system comprising: (a) a catheter comprising(i) a tube, the tube having (A) a wall with an outer surface, the outersurface having a first cross-sectional area, (B) a lumen, (C) a distalend with one or more openings in communication with the lumen, and (D) aproximal end with an opening in communication with the lumen, (ii) avalve that is operated to be in (A) a closed configuration, whereinfluid does not flow out of the proximal end, or (B) an openconfiguration in which fluid does flow out of the proximal end; and(iii) a retainer portion between the distal end and the proximal end,the retainer portion having a maximum cross-sectional area at leasttwice as great as the first cross-sectional area; and (b) a cathetermating device comprising: a stem having a proximal end and a distal end;wherein the distal end includes an apparatus comprising a plurality oftips moveable between (i) a first, retracted configuration, and (ii) asecond, expanded configuration; the apparatus being configured to bereceived in the proximal end of the catheter when in its first,retracted configuration, and configured to engage the proximal end ofthe catheter when in its second, expanded configuration.
 26. Thecatheter system of claim 25, wherein the retainer portion has a maximumcross-sectional area that is 2-3 times greater than the firstcross-sectional area.
 27. The catheter system of claim 25, wherein theretainer portion has a maximum cross-sectional area that is 1.5-4 timeslarger than the first cross-sectional area.
 28. The catheter system ofclaim 25, wherein the retainer portion has a length and the maximumcross-sectional area is at a center of the length.
 29. The cathetersystem of claim 25, wherein the retainer portion has a length and themaximum cross-sectional area extends along part of the length.
 30. Thecatheter system of claim 25, wherein the maximum cross-sectional area isan area from: (24 mm)2π to (25 mm)2π, or (4 mm)2π to (25 mm)²π.
 31. Thecatheter system of claim 25, wherein the retainer portion is circular incross-section at its maximum cross-sectional area, and has a diameter of5 mm to 10 mm at the maximum cross-sectional area.
 32. The cathetersystem of claim 25, wherein the retainer portion has a hardness of anamount from: 1 and 40 Shore A, or 5-15 Shore A, or 10-20 Shore A, or5-15 Shore A, or 10-15 Shore A.
 33. The catheter system of claim 25,wherein the retainer portion is comprised of silicone.
 34. The cathetersystem of claim 25, wherein the retainer portion has an outer surfaceand can be physically compressed to ½ or less of the maximumcross-sectional area when subjected to a compressive force evenlyapplied along the outer surface of the cross-sectional area of an amountfrom: 3-5 lbs., or 2-4 lbs., or 2-6 lbs., or 4-6 lbs., or 5-10 lbs., or7-10 lbs., or 5-22 lbs.
 35. The catheter system of claim 25, wherein theretainer portion is configured to be compressed to have a maximumdiameter of 0.3 mm to 8.0 mm when moved through a penile urethra and tohave a maximum diameter of 4.0 mm to 15 mm when positioned in the bulbarurethra.
 36. The catheter system of claim 25, wherein the retainerportion includes a passage therethrough and part of the tube ispositioned in the passage.
 37. The catheter system of claim 25 thatfurther includes one or more sensors on or in the catheter.
 38. Thecatheter system of claim 37, wherein the one or more sensors arepositioned in a bladder when the catheter is positioned in a lowerurinary tract of a human male.
 39. The catheter system of claim 37,wherein the one or more sensors are positioned at least partially in thelumen.
 40. The catheter system of claim 37, wherein the one or moresensors are configured to collect data of the patient, the datacomprising one or more of: fluid pressure inside of the bladder, fluidvolume inside of the bladder, temperature inside of the bladder, acidityof urine, bacteria level and type in urine, chemical composition ofurine, motion of the patient, location of the patient, and fluid flowwhen emptying the bladder.
 41. The catheter system of claim 37 thatfurther includes one or more antennas, wherein the antennas areconfigured to transmit data received from the one or more sensors. 42.The catheter system of claim 41, wherein the catheter includes a secondlumen and the one or more antennas are positioned in the second lumen.43. The catheter system of claim 25, wherein the catheter mating devicefurther includes a housing connected to the proximal end of the stem.44. The catheter system of claim 25, wherein the stem has an internalpassageway configured to transport bodily fluid.
 45. A catheter systemcomprising: (a) a catheter comprising (i) a tube, the tube having (A) awall with an outer surface, the outer surface having a firstcross-sectional area, (B) a lumen, (C) a distal end with one or moreopenings in communication with the lumen, and (D) a proximal end with anopening in communication with the lumen, (ii) a valve that is operatedto be in (A) a closed configuration, wherein fluid does not flow out ofthe proximal end, or (B) an open configuration in which fluid does flowout of the proximal end; and (iii) a retainer portion between the distalend and the proximal end, the retainer portion having a maximumcross-sectional area at least twice as great as the firstcross-sectional area; (b) a catheter mating device comprising: a stemhaving a proximal end and a distal end; wherein the distal end includesan apparatus having (i) a first, retracted configuration, and (ii) asecond, expanded configuration; the apparatus being configured to bereceived in the proximal end of the catheter when in its first,retracted configuration, and configured to engage the proximal end ofthe catheter when in its second, expanded configuration; (c) one or moresensors on or in the catheter; and (d) one or more antennas, wherein theantennas are configured to transmit data received from the one or moresensors.
 46. The catheter system of claim 45, wherein the retainerportion has a maximum cross-sectional area that is 2-3 times greaterthan the first cross-sectional area.
 47. The catheter system of claim45, wherein the retainer portion has a maximum cross-sectional area thatis 1.5-4 times larger than the first cross-sectional area.
 48. Thecatheter system of claim 45, wherein the retainer portion has a lengthand the maximum cross-sectional area is at a center of the length. 49.The catheter system of claim 45, wherein the retainer portion has alength and the maximum cross-sectional area extends along part of thelength.
 50. The catheter system of claim 45, wherein the maximumcross-sectional area is an area from: (24 mm)2π o (25 mm)2π, or (4 mm)2πto (25 mm)²π.
 51. The catheter system of claim 45, wherein the retainerportion is circular in cross-section at its maximum cross-sectionalarea, and has a diameter of 5 mm to 10 mm at the maximum cross-sectionalarea.
 52. The catheter system of claim 45, wherein the retainer portionhas a hardness of an amount from: 1 and 40 Shore A, or 5-15 Shore A, or10-20 Shore A, or 5-15 Shore A, or 10-15 Shore A.
 53. The cathetersystem of claim 45, wherein the retainer portion is comprised ofsilicone.
 54. The catheter system of claim 45, wherein the retainerportion has an outer surface and can be physically compressed to ½ orless of the maximum cross-sectional area when subjected to a compressiveforce evenly applied along the outer surface of the cross-sectional areaof an amount from: 3-5 lbs., or 2-4 lbs., or 2-6 lbs., or 4-6 lbs., or5-10 lbs., or 7-10 lbs., or 5-22 lbs.
 55. The catheter system of claim45, wherein the retainer portion is configured to be compressed to havea maximum diameter of 0.3 mm to 8.0 mm when moved through a penileurethra and to have a maximum diameter of 4.0 mm to 15 mm whenpositioned in the bulbar urethra.
 56. The catheter system of claim 45,wherein the retainer portion includes a passage therethrough and part ofthe tube is positioned in the passage.
 57. The catheter system of claim45, wherein the one or more sensors are positioned in a bladder when thecatheter is positioned in a lower urinary tract of a human male.
 58. Thecatheter system of claim 45, wherein the one or more sensors arepositioned at least partially in the lumen.
 59. The catheter system ofclaim 45, wherein the one or more sensors are configured to collect dataof the patient, the data comprising one or more of: fluid pressureinside of the bladder, fluid volume inside of the bladder, temperatureinside of the bladder, acidity of urine, bacteria level and type inurine, chemical composition of urine, motion of the patient, location ofthe patient, and fluid flow when emptying the bladder.
 60. The cathetersystem of claim 45, wherein the catheter mating device further includesa housing connected to the proximal end of the stem.
 61. The cathetersystem of claim 45, wherein the stem has an internal passagewayconfigured to transport bodily fluid.
 62. The catheter system of claim45, wherein the catheter mating device further includes (a) a controlhaving a first position and a second position, and (b) a cylinderattached to the control, wherein the cylinder is in a retracted positionwhen the control is in its first position and the cylinder is in anextended position when the control is in its second position, and thecylinder contacts the apparatus and moves it into the second, expandedposition when the cylinder is in its extended position.